Urinary Tract InfectionsNCT03526484
The Utility of Urinalysis Prior to In-Office Procedures
A study testing Experimental in people with Urinary Tract Infections, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 664 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2018to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving an in office cystoscopy, intravesical BCG treatment, or prostate biopsy
Who cannot join
- Patients under 18
- Patients with symptomatic UTI infections at the time of recruitment
- Patients on antibiotics at the time of recruitment, not including prophylaxis
- Patients with a history of UTI within 1 year
- Patients with indwelling catheters
- Patients with clean intermittent catheterization
- Patients undergoing stent removals or with ureteral stents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, 53705
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: The Utility of Urinalysis Prior to In-Office Procedures: A Randomized Clinical Trial
The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.
Read the detailed description
OVERVIEW:
Current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures. If the patient's urinalysis is positive, they are then required to have a urine culture done, which takes 1-3 days to show results, and they may also be prescribed antibiotics. This practice may cause diagnostic delays, unnecessary cancellations of procedures, and the overuse of antibiotics.
The aim of this study is to assess the usefulness of urinalysis labs and urine cultures in patients prior to in-office cystoscopies, intravesical BCG treatments, and prostate biopsies. The investigators predict there is no difference in the number of cases of urinary tract infections in patients that undergo in-office procedures with or without a prior urinalysis. The investigators propose a change in protocol could allow for improved clinical efficiency, antibiotic stewardship, and be economically advantageous.
OUTLINE:
Participants will be randomly assigned to either receive standard of care before their procedure or have their procedure conducted by their provider without consulting the urinalysis results beforehand. Participants will have follow up questionnaires seven days and thirty days after their procedure. A total of 664 participants will be enrolled between the two study sites.
- Conditions
- Urinary Tract Infections
- Being tested
- Standard of Care, Experimental
- Keywords
- UTI, Urinalysis, Urine Culture, Cystoscopy, BCG treatment, Prostate Biopsy
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.
ExperimentalBehavioural
The provider will not review the urinalysis results prior to conducting the in-office procedure, and therefore will not make clinical decisions taking those results into account.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | The control group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will be reported to the doctor performing the procedure. The provider may require participants to take antibiotics and/or delay their procedure as a result of the urinalysis. Receives: Behavioral: Standard of Care |
| Experimental | Experimental | The experimental group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will NOT be reported to the doctor performing the procedure. Instead, the provider will conduct the procedure without looking at or acting upon the results of the urinalysis. The urinalysis and urine culture results will be monitored by the research team, and the participant will be informed if the urine culture results are positive for an infection. Receives: Behavioral: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients who Developed a Urinary Tract Infection Post Procedure
Will compare difference in overall UTI rate between control and experimental groups.The results of the trial will be analyzed using a T-test for comparison of means, a Mann-Whitney U test for comparison of medians, Fisher's exact and chi-squared tests for comparison of categorical variables, and a logistic regression for predictors of UTI.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start28 Sep 2018
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle A Richards, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526484
- Sponsor's protocol ID
- 2017-1124
- Other IDs
- Protocol Version 5/28/2020, A539998, SMPH\VOLUNTEER STAFF\UROLOGY
- Status last verified
- Nov 2021
- First submitted
- 3 May 2018
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Urinalysis Prior to In-Office Procedures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03526484
- Acronym / sponsor ID
- 2017-1124
- Conditions
- Urinary Tract Infections
- Keywords
- UTI, Urinalysis, Urine Culture, Cystoscopy, BCG treatment, Prostate Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.
Detailed description
OVERVIEW:
Current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures. If the patient's urinalysis is positive, they are then required to have a urine culture done, which takes 1-3 days to show results, and they may also be prescribed antibiotics. This practice may cause diagnostic delays, unnecessary cancellations of procedures, and the overuse of antibiotics.
The aim of this study is to assess the usefulness of urinalysis labs and urine cultures in patients prior to in-office cystoscopies, intravesical BCG treatments, and prostate biopsies. The investigators predict there is no difference in the number of cases of urinary tract infections in patients that undergo in-office procedures with or without a prior urinalysis. The investigators propose a change in protocol could allow for improved clinical efficiency, antibiotic stewardship, and be economically advantageous.
OUTLINE:
Participants will be randomly assigned to either receive standard of care before their procedure or have their procedure conducted by their provider without consulting the urinalysis results beforehand. Participants will have follow up questionnaires seven days and thirty days after their procedure. A total of 664 participants will be enrolled between the two study sites.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Standard of CareThe control group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will be reported to the doctor performing the procedure. The provider may require participants to take antibiotics and/or delay their procedure as a result of the urinalysis. |
| Experimental | Experimental | Behavioral: ExperimentalThe experimental group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will NOT be reported to the doctor performing the procedure. Instead, the provider will conduct the procedure without looking at or acting upon the results of the urinalysis. The urinalysis and urine culture results will be monitored by the research team, and the participant will be informed if the urine culture results are positive for an infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving an in office cystoscopy, intravesical BCG treatment, or prostate biopsy
Key exclusion criteria (7 listed)
- Patients under 18
- Patients with symptomatic UTI infections at the time of recruitment
- Patients on antibiotics at the time of recruitment, not including prophylaxis
- Patients with a history of UTI within 1 year
- Patients with indwelling catheters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareThe provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results. | Behavioural | Standard of Care |
| ExperimentalThe provider will not review the urinalysis results prior to conducting the in-office procedure, and therefore will not make clinical decisions taking those results into account. | Behavioural | Experimental |
Primary outcome
Proportion of Patients who Developed a Urinary Tract Infection Post Procedure
Time frame: 1 year
Will compare difference in overall UTI rate between control and experimental groups.The results of the trial will be analyzed using a T-test for comparison of means, a Mann-Whitney U test for comparison of medians, Fisher's exact and chi-squared tests for comparison of categorical variables, and a logistic regression for predictors of UTI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle A Richards, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Urinary Tract Infections, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients who Developed a Urinary Tract Infection Post Procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.